- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00719264
Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
February 13, 2017 updated by: Novartis Pharmaceuticals
A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney
To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
365
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bruxelles, Belgium, 1200
- Novartis Investigative Site
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Bruxelles, Belgium, 1070
- Novartis Investigative Site
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Charleroi, Belgium, 6000
- Novartis Investigative Site
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Kortrijk, Belgium, 8500
- Novartis Investigative Site
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Leuven, Belgium, 3000
- Novartis Investigative Site
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Liege, Belgium, 4000
- Novartis Investigative Site
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RJ
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Rio de Janeiro, RJ, Brazil, 20230-130
- Novartis Investigative Site
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RS
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Porto Alegre, RS, Brazil, 90610-000
- Novartis Investigative Site
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Porto Alegre, RS, Brazil, 90560-030
- Novartis Investigative Site
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SP
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Ribeirao Preto, SP, Brazil, 14015-130
- Novartis Investigative Site
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Santo Andre, SP, Brazil, 09060-650
- Novartis Investigative Site
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São Paulo, SP, Brazil, 01246-000
- Novartis Investigative Site
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Olomouc, Czech Republic, 775 20
- Novartis Investigative Site
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Prague, Czech Republic, 140 00
- Novartis Investigative Site
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Cairo, Egypt
- Novartis Investigative Site
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Avignon, France, 84000
- Novartis Investigative Site
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Bordeaux Cedex, France, 33075
- Novartis Investigative Site
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Caen Cedex, France, 14021
- Novartis Investigative Site
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La Roche sur Yon Cedex, France, 85925
- Novartis Investigative Site
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Montellier cedex 5, France, 34298
- Novartis Investigative Site
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Nantes cedex 2, France, 44202
- Novartis Investigative Site
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Reims, France, 51100
- Novartis Investigative Site
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Rouen Cedex, France, 76031
- Novartis Investigative Site
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Strasbourg Cedex, France, 67010
- Novartis Investigative Site
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Suresnes, France, 92150
- Novartis Investigative Site
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Toulouse Cedex 9, France, 31059
- Novartis Investigative Site
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Cedex
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Strasbourg, Cedex, France, 67091
- Novartis Investigative Site
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Berlin, Germany, 10117
- Novartis Investigative Site
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Berlin, Germany, 13055
- Novartis Investigative Site
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Dessau, Germany, 06846
- Novartis Investigative Site
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Essen, Germany, 45122
- Novartis Investigative Site
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Frankfurt, Germany, 60590
- Novartis Investigative Site
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Frankfurt, Germany, 60488
- Novartis Investigative Site
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Göttingen, Germany, 37075
- Novartis Investigative Site
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Hamburg, Germany, 20246
- Novartis Investigative Site
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Hannover, Germany, 30625
- Novartis Investigative Site
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Heidelberg, Germany, 69115
- Novartis Investigative Site
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Leipzig, Germany, 04109
- Novartis Investigative Site
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Mainz, Germany, 55131
- Novartis Investigative Site
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Tübingen, Germany, 72076
- Novartis Investigative Site
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Shatin, New Territories, Hong Kong
- Novartis Investigative Site
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Tuen Mun, Hong Kong
- Novartis Investigative Site
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Budapest, Hungary, 1086
- Novartis Investigative Site
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Budapest, Hungary, 1122
- Novartis Investigative Site
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Napoli, Italy, 80131
- Novartis Investigative Site
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BS
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Brescia, BS, Italy, 25123
- Novartis Investigative Site
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CR
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Cremona, CR, Italy, 26100
- Novartis Investigative Site
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CZ
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Catanzaro, CZ, Italy, 88100
- Novartis Investigative Site
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FI
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Firenze, FI, Italy, 50134
- Novartis Investigative Site
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MI
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Milano, MI, Italy, 20133
- Novartis Investigative Site
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MO
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Modena, MO, Italy, 41100
- Novartis Investigative Site
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PG
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Perugia, PG, Italy, 06129
- Novartis Investigative Site
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PN
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Aviano, PN, Italy, 33081
- Novartis Investigative Site
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PV
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Pavia, PV, Italy, 27100
- Novartis Investigative Site
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RM
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Roma, RM, Italy, 00152
- Novartis Investigative Site
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Roma, RM, Italy, 00128
- Novartis Investigative Site
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TN
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Trento, TN, Italy, 38100
- Novartis Investigative Site
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VR
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Negrar, VR, Italy, 37024
- Novartis Investigative Site
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Daegu, Korea, Republic of, 705-703
- Novartis Investigative Site
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Seoul, Korea, Republic of, 136-705
- Novartis Investigative Site
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Taegu, Korea, Republic of, 700 -721
- Novartis Investigative Site
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Gyeonggi-do
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Goyang, Gyeonggi-do, Korea, Republic of, 03722
- Novartis Investigative Site
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Korea
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Seoul, Korea, Korea, Republic of, 06351
- Novartis Investigative Site
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Leiden, Netherlands, 2333 ZA
- Novartis Investigative Site
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Moscow, Russian Federation, 115478
- Novartis Investigative Site
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Moscow, Russian Federation, 125284
- Novartis Investigative Site
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Saint Petersburg, Russian Federation, 191104
- Novartis Investigative Site
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Saint-Petersburg, Russian Federation, 197758
- Novartis Investigative Site
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Russia
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Obninsk, Russia, Russian Federation, 249036
- Novartis Investigative Site
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Singapore, Singapore, 258500
- Novartis Investigative Site
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Johannesburg, South Africa, 2196
- Novartis Investigative Site
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Pretoria, South Africa, 0001
- Novartis Investigative Site
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Pretoria, South Africa, 0044
- Novartis Investigative Site
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Barcelona, Spain, 08041
- Novartis Investigative Site
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Madrid, Spain, 28041
- Novartis Investigative Site
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Madrid, Spain, 28034
- Novartis Investigative Site
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Santander, Spain, 39008
- Novartis Investigative Site
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Zaragoza, Spain, 50009
- Novartis Investigative Site
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Andalucía
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Jaen, Andalucía, Spain, 23007
- Novartis Investigative Site
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Cantabria
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Santander, Cantabria, Spain, 39008
- Novartis Investigative Site
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Bern, Switzerland, 3010
- Novartis Investigative Site
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Chur, Switzerland, 7000
- Novartis Investigative Site
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Lin-Kou, Taiwan, 33305
- Novartis Investigative Site
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Taichung, Taiwan, 40705
- Novartis Investigative Site
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Taipei, Taiwan, 10002
- Novartis Investigative Site
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Taipei, Taiwan, 114
- Novartis Investigative Site
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Taiwan, ROC
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Taipei, Taiwan, ROC, Taiwan, 112
- Novartis Investigative Site
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Bangkok, Thailand, 10330
- Novartis Investigative Site
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Songkla, Thailand, 90110
- Novartis Investigative Site
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Adana, Turkey, 01330
- Novartis Investigative Site
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Altunizade, Turkey, 34662
- Novartis Investigative Site
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Ankara, Turkey, 06100
- Novartis Investigative Site
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Antalya, Turkey, 07070
- Novartis Investigative Site
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Balcova / Izmir, Turkey, 35340
- Novartis Investigative Site
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Bursa, Turkey, 16059
- Novartis Investigative Site
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Mecidiyekoy/Istanbul, Turkey, 34394
- Novartis Investigative Site
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Glasgow, United Kingdom, G12 0YN
- Novartis Investigative Site
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Southampton, United Kingdom, SO16 6YD
- Novartis Investigative Site
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Middlesex
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Northwood, Middlesex, United Kingdom, HA6 2RN
- Novartis Investigative Site
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Arkansas
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Fayetteville, Arkansas, United States, 72703
- Highlands Oncology Group Dept of Highlands Oncology Grp
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California
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Duarte, California, United States, 91010-3000
- City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)
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Los Angeles, California, United States, 90053
- USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
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Los Angeles, California, United States, 90095
- University of California at Los Angeles Dept. of Hem/Oncology
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)
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Nevada
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Las Vegas, Nevada, United States, 89135
- Nevada Cancer Institute Dept. of Nevada Cancer (3)
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Pennsylvania
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Bethlehem, Pennsylvania, United States
- St. Luke's Hospital and Health Network St. Luke's Cancer Network
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Texas
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Irving, Texas, United States, 75038
- Las Colinas Hematology Oncology Grapevine
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Washington
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Seattle, Washington, United States, 98105
- Seattle Cancer Care Alliance Dept. of SCCA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with metastatic renal cell carcinoma
- Patients with at least one measurable lesion
- Patients with progressive metastatic renal cell carcinoma
- Patients who had a prior partial or complete nephrectomy
- Patients with a Karnofsky Performance Status ≥70%.
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Adequate coagulation profile
Exclusion Criteria:
- 4 weeks post-major surgery
- Patients who had radiation therapy within 28 days prior to start of study
- Patients in need for major surgical procedure during the course of the study.
- Patients with a serious non-healing wound, ulcer, or bone fracture.
- Patients with a history of seizure(s) not controlled with standard medical therapy.
- Patients who have received prior systemic treatment for their metastatic RCC.
- Patients who received prior therapy with VEGF pathway inhibitor
- Patients who have previously received systemic mTOR inhibitors
- Patients with a known hypersensitivity RAD001 (everolimus) or other rapamycins or to its excipients.
- Patients with history or current central nervous system (CNS) metastases or spinal cord compression.
- Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
- Patients with proteinuria at screening.
- Patients with inadequately controlled hypertension
- Patients receiving ongoing or with recent need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin
- Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
- Patients with a known history of HIV
- Patients with hypersensitivity to interferon alfa-2a or any component of the product.
- Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism
- Patients who have any severe and/or uncontrolled medical conditions or other conditions
- Left Ventricular Ejection Fraction < lower limit of institutional normal assessed by ECHO or MUGA
- Patients who have a history of another primary malignancy ≤ 3 years
- Female patients who are pregnant or breast feeding
- Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
- Patients unwilling to or unable to comply with the protocol
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: bevacizumab, RAD001 (everolimus)
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks
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10 mg qd
Other Names:
10 mg/kg every 2 weeks
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ACTIVE_COMPARATOR: bevacizumab, interferon alfa-2a (IFN)
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks
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10 mg/kg every 2 weeks
dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Time Frame: Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.
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Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0.
All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial.
All scans were reviewed by independent, central radiology.
Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
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Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Time Frame: Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)
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Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.
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Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)
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Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Time Frame: Time from first participant randomized until 31Dec2011, cutoff date.
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Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR).
Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression.
Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression.
CR required a disappearance of all target and non-target lesions.
PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters.
Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
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Time from first participant randomized until 31Dec2011, cutoff date.
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Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Time Frame: Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.
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The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first.
If no event, participant is censored at the last adequate assessment.
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Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.
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Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths
Time Frame: From the first participant randomized until the last patient discontinued the study treatment + 28 days
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Participants were monitored for adverse events, serious adverse events and deaths throughout the study.
Participants were assessed continuously at each 28-day cycle.
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From the first participant randomized until the last patient discontinued the study treatment + 28 days
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Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units
Time Frame: Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011
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The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer.
Each item is scored on a 5-point scale (0 = not at all; 4 = very much).
If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36.
Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score.
The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms).
Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study.
A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.
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Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011
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Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%
Time Frame: Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011
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The EORTC QLQ-C30 contains 30 items.
These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact).
The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much).
The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life.
Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study.
A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.
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Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011
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Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab
Time Frame: From the date of the first participant treated until the last patient discontinued the study treatment + 28 days
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This outcome measure was assessed continuously.
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From the date of the first participant treated until the last patient discontinued the study treatment + 28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 12, 2008
Primary Completion (ACTUAL)
December 31, 2011
Study Completion (ACTUAL)
April 15, 2013
Study Registration Dates
First Submitted
July 15, 2008
First Submitted That Met QC Criteria
July 18, 2008
First Posted (ESTIMATE)
July 21, 2008
Study Record Updates
Last Update Posted (ACTUAL)
March 20, 2017
Last Update Submitted That Met QC Criteria
February 13, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Interferons
- Interferon-alpha
- Interferon alpha-2
- Bevacizumab
- Everolimus
Other Study ID Numbers
- CRAD001L2201
- 2008-000077-38 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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